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Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00733265
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The main purpose of this study is to examine how AZD6140 affects patients with severe kidney disease compared to volunteers with normal kidneys. Subjects in the study will receive one dose of AZD6140.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: AZD6140 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
Study Start Date : February 2007
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Ticagrelor
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: AZD6140 Drug: AZD6140
single oral dose


Outcome Measures

Primary Outcome Measures :
  1. Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys [ Time Frame: Scheduled times during the 3 days after the study drug is taken ]

Secondary Outcome Measures :
  1. Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys [ Time Frame: Screening through completion of the study ]
  2. Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys [ Time Frame: Scheduled times during the 3 days after the study drug is taken ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must have severe kidney disease
  • Subjects who are matched to the kidney disease patients in terms of weight, age, and sex must have normal kidneys
  • All women must be post-menopausal (no longer menstruating) or surgically sterile

Exclusion Criteria:

  • Patients requiring dialysis
  • History of allergy to aspirin or clopidogrel
  • Have increased bleeding risk (for instance uncontrolled high blood pressure or a recent major injury)
  • Recent history of fainting or light-headedness
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733265


Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, California
Research Site
Anaheim, California, United States
United States, Florida
Research Site
Miami, Florida, United States
United States, Texas
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Kathleen Butler, MD AstraZeneca
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jay Horrow, MD, Medical Science Director, AZD6140, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00733265     History of Changes
Other Study ID Numbers: D5130C00015
AZD6140/Renal Study
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Renal Impairment

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs